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Q3 results

- PMLiVE

CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

- PMLiVE

EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

- PMLiVE

FDA opens door to COVID-19 booster jabs

FDA approves third shot of mRNA vaccine for the immunocompromised but EMA says there’s “not yet enough data”

- PMLiVE

NICE approval for Lilly’s Verzenios is “fantastic news for thousands of women”

NICE declares Lilly’s breast cancer drug to be cost-effective, allowing routine use on the NHS

- PMLiVE

FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

- PMLiVE

Valneva’s COVID-19 vaccine to be tested in older people

The trial for VLA2001 will involve people over the age of 56 in New Zealand and aims to generate additional safety and immunogenicity data in older people

- PMLiVE

South Korean company SK bioscience moves into phase 3 trials for its COVID-19 vaccine

Part of the Wave 2 vaccine programme, GBP510 will bolster South Korea’s domestic supply if successful

- PMLiVE

FDA requests further safety trials for AZ, FibroGen’s roxadustat

The response follows concerns over serious thrombotic events and seizures

- PMLiVE

BioNTech to use COVID vaccine profits to “expand and accelerate” pipeline

Vaccine maker posts first-half profits of €3.9bn compared to a loss of €142m a year earlier as demand for the innovative mRNA jab remains strong

- PMLiVE

Moderna deal to build state-of-the-art manufacturing plant bolsters Canada’s vaccine production

The new manufacturing facility will enhance the country’s “rapid pandemic response capabilities”

- PMLiVE

Gene therapy company bluebird bio quits Europe

The decision comes after a trial in a rare neurological disease is halted over safety concerns and the FDA has placed the eli-cel programme on clinical hold

- PMLiVE

AZ publishes new real-world safety data for COVID-19 vaccine Vaxzevria

Real-world data shows similar safety profile for Vaxzevria and mRNA-based jabs

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